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Efficacy and safety of HAT1 compared with calcipotriol in the treatment of patients with mild to moderate chronic plaque psoriasis: results from an open-label randomized comparative pilot clinical study.
Alex, P, Williams, S, Sutton, L, Yesudas, T, Sutton, C, Thomas, S, Centola, M
Clinical and experimental dermatology. 2020;(3):318-322
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Abstract
Psoriasis is commonly treated with topical corticosteroids, oral cytotoxic drugs and biologic agents, which can be associated with significant adverse effects (AEs), high cost and response attenuation. Additionally, patients often use alternative therapies ad hoc, which can be challenging to integrate into a treatment regimen, owing to a lack of adequately powered controlled trials assessing efficacy and safety. We developed a novel topical botanical complex, herbal anti-inflammatory treatment (HAT1), through extensive preclinical in vitro and in vivo modelling to define key mechanisms of action and clinical potential. To assess the efficacy and safety of HAT1 in psoriasis, we performed a 10-week, open-label, pilot clinical trial comparing topical treatment of HAT1 with calcipotriol 0.005% in adult patients with mild to moderate psoriasis. Primary and secondary endpoints included the percentage of patients obtaining improvement of ≥ 75% in Psoriasis Area and Severity Index (PASI 75), Physician's Global Assessment (PGA) response, and evaluation of tolerability and safety of HAT1. In the HAT1 arm, 85.7% of study patients reached PASI 75 compared with 21.4% in the calcipotriol comparator group. Additionally, 78.6% of patients in the HAT1 arm achieved a 'clear' or 'minimal' PGA response. HAT1 was well tolerated, with no AEs observed throughout the trial. These results suggest that HAT1 reduces psoriasis disease activity in a clinically relevant manner. Ongoing studies, including well-powered, double-blind, randomized controlled trials will be required to assess the potential of HAT1 in psoriasis.
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Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.
Wu, JJ, Hansen, JB, Patel, DS, Nyholm, N, Veverka, KA, Swensen, AR
Journal of medical economics. 2020;(6):641-649
Abstract
Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion.Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis.Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated.Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294).Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.
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Epidemiology of Psoriasis. A Population-Based Study.
Fernández-Armenteros, JM, Gómez-Arbonés, X, Buti-Solé, M, Betriu-Bars, A, Sanmartin-Novell, V, Ortega-Bravo, M, Martínez-Alonso, M, Casanova-Seuma, JM
Actas dermo-sifiliograficas. 2019;(5):385-392
Abstract
BACKGROUND AND OBJECTIVES Psoriasis is a chronic immunoinflammatory skin disease very frequent in the western world. Several authors have tried to calculate its prevalence in different regions, although most of them obtained the data from surveys and there are few publications from Mediterranean areas. The objective of our study was to analyze the prevalence and severity of psoriasis in Lleida (a northeastern region in Spain), identify age and sex specific differences and compare our results with other European series. MATERIALS AND METHODS A joint database of primary care medicine and the dermatology department was obtained from the entire province of Lleida with epidemiological data and psoriasis diagnosis and treatment codification. RESULTS A corrected database was obtained with 398,701 individuals and 6,868 of them (1.72%) were coded with the diagnosis of psoriasis. The prevalence was significantly higher in men than in women (1.88% vs 1.56%, OR=1.21, 95% CI: 1.15-1.27). The highest prevalence of psoriasis was found in the 61-70 years group (2.90%) and psoriasis in population under 18 years of age was 0.30%. In our sample, 7.27% of the patients were classified as moderate-severe psoriasis (499/6,868). CONCLUSION This study reports the prevalence and severity of psoriasis in a large Mediterranean region sample, obtaining the information through a electronic database. This study reveals a lower prevalence of psoriasis compared to other European countries, and the proportion of severe psoriasis (based on treatment criteria) is lower than in other studies. We emphasize that these differences could probably due to genetic background, life style and diet.
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[Analysis of the Cochrane Review: Topical Treatments for Scalp Psoriasis. Cochrane Database Syst Rev. 2016;2:CD009687].
Queirós, CS, Duarte, GS, Costa, J, Vaz-Carneiro, A
Acta medica portuguesa. 2017;(3):163-168
Abstract
Regardless the psoriasis subtype, up to 79% of people with this skin condition present scalp involvement, which is often the first site to show symptoms of the disease. In addition to being itchy, the red and scaly lesions are usually easy to see, and may be embarrassing. Topical therapy is usually the first line of treatment; however the wide array of available interventions can make the choice difficult, and may even lead to an inadequate treatment. The objective of this review was to evaluate the efficacy and safety of topical treatments for scalp psoriasis. A systematic review was performed according to the methodology recommended by Cochrane in order to evaluate the clinical severity of psoriasis, quality of life, and adverse events that led to treatment discontinuation. To evaluate this, 59 studies were included, with a total of 11 561 participants, and 15 comparisons were made between the various drugs and application vehicles tested. The principal conclusion is that corticosteroids of high or very high potency are more effective than vitamin D. The combination of a corticosteroid with vitamin D has only a marginal benefit over corticosteroid monotherapy, but is superior to vitamin D alone. Given the similar safety profile and only marginal benefit of the combination of corticosteroid with vitamin D over the corticosteroid alone, topical corticosteroid monotherapy appears to be fully acceptable for short-term therapy of scalp psoriasis.
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Fixed combination calcipotriol plus betamethasone dipropionate aerosol foam in the treatment of psoriasis vulgaris: rationale for development and clinical profile.
Paul, C, Bang, B, Lebwohl, M
Expert opinion on pharmacotherapy. 2017;(1):115-121
Abstract
Psoriasis is a chronic, immune-mediated inflammatory disorder with a significant negative impact on quality of life. Most patients with mild-to-moderate psoriasis manage their disease with topical therapies; the most commonly used formulations contain corticosteroids and/or vitamin D3 analogues. However, adherence to topical treatment remains a significant issue as the daily treatment regimen can be cumbersome and time consuming and many patients do not obtain complete/almost complete clearance. Areas covered: Published pre-clinical and clinical data evaluating calcipotriol 50 µg/g (Cal) and betamethasone 0.5 mg/g as dipropionate (BD) aerosol foam in patients with psoriasis. Expert opinion: Cal/BD aerosol foam, a once-daily, alcohol-free, paraffin-based vehicle with emollient properties, was developed to increase the therapeutic options available to patients. Cal/BD aerosol foam is rapidly effective for treating psoriasis and the greater efficacy compared with the ointment and gel formulations is consistent and clinically relevant. This enhanced efficacy is due to improved skin penetration of the active ingredients following the formation of a stable supersaturated solution on the skin. Studies have shown increasing patient satisfaction with Cal/BD aerosol foam. It is hoped that this optimized formulation of Cal/BD will improve adherence and help to address the unmet medical needs of patients with mild-to-moderate psoriasis.
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Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis.
Queille-Roussel, C, Rosen, M, Clonier, F, Nørremark, K, Lacour, JP
Clinical drug investigation. 2017;(4):355-361
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Abstract
BACKGROUND Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas. OBJECTIVE The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis. METHODS In this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas. RESULTS Thirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated. CONCLUSION Cal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis. CLINICAL TRIAL REGISTRATION NUMBER NCT02518048.
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A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis.
Sugarman, JL, Gold, LS, Lebwohl, MG, Pariser, DM, Alexander, BJ, Pillai, R
Journal of drugs in dermatology : JDD. 2017;(3):197-204
Abstract
UNLABELLED BACKGROUND Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. Topical corticosteroids are the mainstay of treatment, however long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may improve psoriasis signs at a lower corticosteroid concentration providing a superior safety profile. OBJECTIVE To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate-to-severe plaque psoriasis. METHODS Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'Clear' or 'Almost Clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Safety and treatment emergent adverse events (TEAEs) were evaluated throughout. RESULTS HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as 2 weeks. At week 8, 52.5% of subjects had treatment success compared with 33.3%, 18.6%, and 9.7% in the HP (P=0.033), TAZ (P less than 0.001), and vehicle (P less than 0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, a 2-grade improvement in IGA was achieved by 54.2% of subjects for erythema, 67.8% for plaque elevation, and 64.4% for scaling. Most frequently reported TEAEs were application site reactions, and were more likely associated with the tazarotene component. Side effects such as skin atrophy were rare. CONCLUSIONS HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene, and did not reveal any new safety concerns with the combination product.
J Drugs Dermatol. 2017;16(3):197-204.
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Economic burden of psoriatic patients in Japan: Analysis from a single outpatient clinic.
Takahashi, H, Satoh, K, Takagi, A, Iizuka, H
The Journal of dermatology. 2017;(9):1024-1026
Abstract
Topical and systemic agents have dramatically improved the treatment efficacy of psoriasis. Few reports, however, exist describing the economic burden in Japanese psoriatic patients. The aim of the study was to evaluate the total costs as well as cost versus efficacy of topical and systemic treatments of psoriatic patients under the Japanese health insurance system. The retrospective study was performed from the database of our clinic, which is located in Hokkaido Prefecture. Cost and effectiveness of psoriatic patients were evaluated during the 12-month period from April 2015 to March 2016. Data were collected and calculated for the total cost per year, treatment efficacy and cost versus efficacy. The mean total cost of topical corticosteroid treatment was ¥18 184/year and was lowest among the treatments. The systemic treatment with biologics was most expensive and the costs were over ¥400 000/year. Among the topical treatments, calcipotriol/betamethasone dipropionate was most expensive (¥34 693/year). However, cost versus efficacy was not significantly different from that of topical corticosteroid treatments. The cost of secukinumab was highest among all the treatments (¥631 600/year). However, treatment day per cost was lowest of all the psoriasis treatments. Biologics showed the highest cost than topical or systemic treatments. However, they showed most marked efficacy in terms of improving the psoriatic skin lesions.
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Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.
Koo, J, Tyring, S, Werschler, WP, Bruce, S, Olesen, M, Villumsen, J, Bagel, J
The Journal of dermatological treatment. 2016;(2):120-7
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Abstract
BACKGROUND An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment. OBJECTIVES To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks. METHODS In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity. RESULTS In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch). CONCLUSIONS Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.
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Real-life effectiveness of once-daily calcipotriol and betamethasone dipropionate gel vs. ointment formulations in psoriasis vulgaris: final analysis of the 52-week PRO-long study.
Lambert, J, Hol, CW, Vink, J
Journal of the European Academy of Dermatology and Venereology : JEADV. 2015;(12):2349-55
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Abstract
BACKGROUND Topical therapies are the mainstay of treatment for psoriasis vulgaris. The fixed combination of calcipotriol (Cal) 50 μg/g plus betamethasone 0.5 mg/g (as dipropionate; BD) is a first-line topical treatment and available as a gel or ointment. The use of these fixed combination products was compared in PRO-long, a long-term noninterventional study, for which interim results (4 and 12 weeks) have previously been reported. OBJECTIVE To describe and compare patients' perspectives on the fixed combination gel and ointment formulations; to include efficacy, adherence behaviour, treatment satisfaction and health-related quality of life (HRQoL) aspects during long-term real-life psoriasis management. METHODS PRO-long was a multicentre, prospective, observational, 52-week study of patients prescribed fixed combination Cal/BD gel or ointment in clinical practice. For final analysis the following were assessed at weeks 24, 36 and 52: differences in the proportion of patients with 'mild'/'very mild' disease according to patient's global assessment of disease severity, adherence behaviour, treatment satisfaction (nine-item treatment satisfaction questionnaire for medication) and HRQoL (Skindex-29). RESULTS Patients (n = 328) were prescribed once-daily Cal/BD gel (n = 152) or ointment (n = 176). At week 52, a higher proportion of patients reported that the severity of their psoriasis was 'mild'/'very mild' vs. baseline (gel: 60.2 vs. 47.1%; ointment: 58.8 vs. 42.4%), with greater treatment satisfaction reported in patients using gel vs. those using ointment. A higher proportion of patients found the gel 'easy' to use compared with the ointment (66.7 vs. 45.2%). Daily application of treatment took ≤ 5 min for 86.1% of patients using gel and 71.0% of patients using ointment. CONCLUSION This real-life study has demonstrated similar effectiveness between the Cal/BD formulations. However, over a 52-week treatment period, patients reported greater treatment satisfaction with the gel, which was considered easier to use, faster to apply and overall a more convenient product.